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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 61-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-4631631-9/1/1 13-Oct-2004 61EBY06 2938970 Mylan Specialty, L.P. United States
 
310-8424047-7/1/1 29-Oct-2004 61EDB06 3004760336 Joanne Crook Canada
 
112-4408014-9/1/2 31-Oct-2004 61FCA54 3004715789 Bayer Portugal Sa Portugal
 
112-4408014-9/1/3 31-Oct-2004 61FCA54 3004715786 Azeona Nidia Dominican Republic
 
T94-0035907-9/1/1 08-Oct-2004 61FCS14 3010221253 LABORATORIOS LOPEZ, S.A DE C.V. El Salvador
 
T94-0034093-9/1/1 18-Oct-2004 61FCS55 3003699941 Cipla Ltd India
 
112-4381203-9/1/1 31-Oct-2004 61IRK99 3004712545 Regal Press Canada Canada
 
144-6314710-0/4/1/B 22-Oct-2004 61KAA06 3003708614 U N D A Belgium
 
112-4287903-9/1/1 22-Oct-2004 61MCA06 3004664806 Roche Saq Ei Argentina
 
112-4218183-2/1/1 17-Oct-2004 61NCA76 3004643023 Schulz Jan Canada
 
AEK-6996924-0/1/1 20-Oct-2004 61NCA99 3004742282 Dural Cody Kirtasiye Ltd Turkey
 
336-2634321-7/1/1 18-Oct-2004 61NCL69 3002808385 Taro Pharmaceutical Industries, Ltd. Israel
 
112-4287903-9/1/2 22-Oct-2004 61NDA80 3004664807 Wyeth Pharma Argentina
 
112-4189347-8/2/1 14-Oct-2004 61PBA31 3004638984 Hoechst Ag Germany
 
112-4189347-8/1/1 14-Oct-2004 61PBA55 3003744061 Merck Sante Sas France
 
310-8423968-5/1/1 29-Oct-2004 61PBL32 3004758784 Bruce Lobay Canada
 
112-4348823-6/1/1 29-Oct-2004 61PCA14 3004707649 Alsharif Abu Talal United Arab Emirates
 
AEK-6996639-4/2/2 22-Oct-2004 61PCB09 3004740421 Apollo Hospitals Enterprise India
 
AEK-6996639-4/2/1 22-Oct-2004 61PCB26 3004740421 Apollo Hospitals Enterprise India
 
AEK-6996639-4/2/3 22-Oct-2004 61PCB99 3004740421 Apollo Hospitals Enterprise India
 
112-4206449-1/1/1 13-Oct-2004 61PCP99 3002807511 Lupin Limited India
 
112-4206449-1/1/2 13-Oct-2004 61PCP99 3002807511 Lupin Limited India
 
112-4206449-1/1/3 13-Oct-2004 61PCP99 3002807511 Lupin Limited India
 
DO7-0084960-0/1/1 20-Oct-2004 61PRY17 1000346340 Ipsen Biopharm Ltd. United Kingdom
 
AEK-6991796-7/4/1 20-Oct-2004 61SCJ99 3004761354 Dar Al Handash Consultants Jordan
 
112-4257190-9/1/1/A 18-Oct-2004 61UDB05 3004370316 Sociedad Estatal Correos Spain
 
AEK-6989656-7/1/1 07-Oct-2004 61VIN01 3004134249 Wyeth Biopharma Ireland
 
582-8249347-8/1/1 29-Oct-2004 61XBB09 3002807542 Allergan Ireland
 
AEK-6994886-3/2/1 07-Oct-2004 61XCA09 3004471682 Halliburton Co Egypt
 
AEK-6991796-7/5/1 20-Oct-2004 61XCA99 3004761354 Dar Al Handash Consultants Jordan
 
AEK-6998197-1/1/1 13-Oct-2004 61XDA45 3004749467 Chroni Georgia Greece
 
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